transparency and quality. These regulations and certifications can be adopted by cannabis, hemp, and CBD industries, although they are not yet required by the FDA at this time.
ISO 9001 is an internationally recognized quality management system, which is generic in nature and can be adopted by any industry regardless of the nature of their service, products, size, location or scope of business.
GMP is the Quality Management System mandated and regulated by the FDA to ensure the quality, safety, and efficiency of the manufacturing process of food or pharmaceutical products. Adoption and certification of ISO standards are voluntary and companies choose to implement ISO in addition to GMP because they are committed to ensuring the quality of their products and streamlining the effectiveness of their processes.
ISO 9001 Certifications are issued for a period of three years, although surveillance audits are conducted every year to maintain the certification. Compliance with GMP requirements is enforced by federal FDA agents and they administer and audit the proper application and interpretation of the GMP standards.
ISO IMPLEMENTATION FOR CBD, CANNABIS, AND HEMP INDUSTRIES
GMP and ISO implementation for Cannabis, CBD, and Hemp industries involve multiple onsite visits and it is recommended that you hire a consultant who is not too far from you. LMG New York offers GMP consultation for Cannabis, CBD, and Hemp industries from our offices in New York and Chicago. We offer a free initial consultation visit and give you a clear picture of the time frame and the fees (fixed fee) involved in the process.
The process for ISO Certification for Cannabis CBD and Hemp industry includes:
- GAP analysis of your existing Quality Management System related to ISO 9001 requirements.
- Developing documents such as quality manual, procedures, forms, templates.
- ISO awareness training
- Review of your Standard Operating Procedures (SOP)
- Implementing a well-documented Quality Management System throughout your organization.
- Internal Audit identifying non-conformities related to ISO 9001 requirements.
- Management Review Meetings
- Corrective and preventive actions /Root cause analysis addressing non-conformities.
- Certification body (Registrar) selection
- Certification body (Registrar) audit support
- Closing of any non-conformities found by the certification body
- Issuance of ISO 9001 Certification.
